FDA device listing
8-Channel Adapter, B, 10cm (Model 2321),8-Channel Adapter, B, 60cm (Model 2326),8-Channel Adapter (Model 2311…
FDA device listing 1213468741 · ABBOTT LABORATORIES
Key facts
| Proprietary names | 8-Channel Adapter, B, 10cm (Model 2321),8-Channel Adapter, B, 60cm (Model 2326),8-Channel Adapter (Model 2311, 2316),A127 Lead Extension,Battery pack (Model 1254),BurstDR stimulation temp evaluation patient programmer (Model 3857),Charger Accessories Kit, lumbar (model 36000),Charger Accessory (Eon Mini LE) (Model 3720),Charger Antenna 36 (Model 3732),Charger (model 16000),Charger (Model… |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | P010032 |
| Product codes | GZB, LGW, QRB |
| Device names | GZB - Stimulator, Spinal-Cord, Implanted (Pain Relief), LGW - Stimulator, Spinal-Cord, Totally Implanted For Pain Relief, QRB - Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy |
| Device class | Class II, Class III |
| Classification regulations (21 CFR) | 882.5880, ORCA1.LGW, ORCA1.QRB |
| Review panels | Neurology |
| Registered establishments | Abbott Medical |
| Establishment registrations | 1627487, 3006705815 |
| FEI numbers | 1627487, 3006705815 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database